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A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470

NCT ID: NCT02302443

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.

Detailed Description

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This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Very low dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Cohort 2

Low dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Cohort 3

Intermediate dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Cohort 4

High dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Cohort 5

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Active comparator

Intervention Type BIOLOGICAL

Single dose subcutaneous administration of active comparator

Cohort 6

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Active comparator

Intervention Type BIOLOGICAL

Single dose subcutaneous administration of active comparator

Interventions

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HM12470

Single dose subcutaneous administration ranging from a very low dose to high dose

Intervention Type BIOLOGICAL

Active comparator

Single dose subcutaneous administration of active comparator

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* T2DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 35.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).


* T1DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 30.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Exclusion Criteria

* A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
* pregnant or lactating women
* participation in an investigational study within 30 days prior to dosing
* Clinically significant abnormal ECG at screening, as judged by the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hanmi Pharmaceuticals Hanmi Pharmaceuticals

Role: STUDY_DIRECTOR

Hanmi Pharmaceuticals

Locations

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Hanmi Pharmaceutical Company

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-INS115-101

Identifier Type: -

Identifier Source: org_study_id